MalnutritionPhase 3NCT00131209
Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants
A Phase 3 study testing fortified spread (RUTF) and maize and soy flour in people with Malnutrition, run by Tampere University at 1 site in Malawi.
Trial summary
This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- fortified spread (RUTF) and maize and soy flour
- How many people
- 180 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2004to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Signed informed consent from at least one guardian
- Ages 5.50 months to 6.49 months
- Availability during the period of the study
- Permanent resident of the area
Who cannot join
- WHZ < -2.0 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation of the child in another clinical trial with intervention to the child
Trial locations and contacts
1 site in 1 country.
Malawi1 site
College of Medicine, University of Malawi
Mangochi, Mangochi District
About this study
Official title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.
Read the detailed description
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18 months).
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.
- Conditions
- Malnutrition
- Being tested
- fortified spread (RUTF), maize and soy flour
- Keywords
- Infant, Sub-Saharan Africa, Complementary feeding, Malnutrition, Growth, Fortified spread, Haemoglobin
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified spread (RUTF)Dietary supplement
maize and soy flourDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain during the 12-month follow-up (in grams)
Secondary outcomes (6)
Length gain during the study period (cm)
Cognitive and motor developmental score at the end of trial
Change in blood haemoglobin concentration during the study period (g/l)
Change in serum ferritin concentration during the study period (µg/l)
Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
Incidence of undernutrition, stunting and wasting (WAZ, WHZ or HAZ < -2.0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startOct 2004
- Primary completionJan 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland, Foundation for Paediatric Research, Finland
- Investigators
- Per Ashorn, MD, PhD, Study director, University of Tampere, Medical SchoolKenneth Maleta, MBBS, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131209
- Sponsor's protocol ID
- SA-1200720-3
- Status last verified
- Jul 2008
- First submitted
- 16 Aug 2005
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.
PubMed 19056572Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619.
PubMed 18606932
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
- ClinicalTrials.gov ID
- NCT00131209
- Acronym / sponsor ID
- SA-1200720-3
- Conditions
- Malnutrition
- Keywords
- Infant, Sub-Saharan Africa, Complementary feeding, Malnutrition, Growth, Fortified spread, Haemoglobin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Academy of Finland, Foundation for Paediatric Research, Finland
- Study start
- Oct 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.
Detailed description
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18 months).
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Signed informed consent from at least one guardian
- Ages 5.50 months to 6.49 months
- Availability during the period of the study
- Permanent resident of the area
Key exclusion criteria (4 listed)
- WHZ < -2.0 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation of the child in another clinical trial with intervention to the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified spread (RUTF) | Dietary supplement | – |
| maize and soy flour | Dietary supplement | – |
Primary outcome
Weight gain during the 12-month follow-up (in grams)
6 secondary outcomes
Length gain during the study period (cm)
Cognitive and motor developmental score at the end of trial
Change in blood haemoglobin concentration during the study period (g/l)
Change in serum ferritin concentration during the study period (µg/l)
Mean change in anthropometric indices (weight-for-age z-score [WAZ], weight-for-height z-score [WHZ] and height-for-age z-score [HAZ])
Incidence of undernutrition, stunting and wasting (WAZ, WHZ or HAZ < -2.0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
- Derived from this study: PubMed 19056572Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.
- Derived from this study: PubMed 18606932Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619.
- College of Medicine home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ashorn, MD, PhD study director
University of Tampere, Medical School
Kenneth Maleta, MBBS, PhD principal investigator
Kamuzu University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fortified spread (RUTF) and maize and soy flour in people with Malnutrition, run by Tampere University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain during the 12-month follow-up (in grams). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131209, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2008.